The UK’s plans to leave the European Union (EU) and the EU’s single market could have serious implications for patients’ access to medicines and medical technologies.
Certain medicines and medical technologies may be delayed in reaching patients or may even become unavailable to patients if no solution for medicines and medical devices is found during the Brexit negotiations.
This briefing from the Brexit Health Alliance - "Brexit and the impact on patient access to medicines and medical technologies" - explores how UK and EU citizens could be affected by the disruption in trade that may result from the UK’s exit from the EU, as well as in the event of a lack of cooperation in the regulation of medicines and devices between the EU and the UK post-Brexit.
The regulation of medicines and medical technologies is managed by EU-wide systems, facilitating trade under the single market. This means that products are regulated to make sure that they are safe before they can be placed on the EU market. They are also closely monitored after being placed on the market to ensure continued safety.
The regulatory arrangements for medicines and medical devices are complex and changes to this regime may have an impact on supplies across Europe. ‘No deal’ or a deal between the UK and the EU that does not address future cooperation on medicines and medical technologies could put public health at risk.
Brexit Health Alliance
As the EU and the UK prepare to move to phase two of the Article 50 negotiations, which will look at the future relationship between the EU and the UK, arrangements for the regulation of medicines and medical devices need be addressed as a matter of urgency.
The Brexit Health Alliance is calling for:
- No negative impact on patients. Future cooperation on medical devices and medicines to be prioritised in the negotiations, so that patients and the wider public are not negatively impacted from disruptions in the supply of medicines and other health technologies, or from a reduction in standards or safety.
- Patient safety and public health to be guaranteed post Brexit through aligning the UK as much as possible with the EU’s regulation of medicines and medical devices, and by close regulatory cooperation between the EU and UK, as proposed by the UK government.
- Pragmatic solutions allowing patients and the public to benefit from the UK’s participation in EU systems such as data sharing networks, pharmacovigilance and the new clinical trials infrastructures post Brexit.
- An implementation period beyond the two years of Article 50 negotiations (which end in March 2019). This period should adequately reflect the time needed to ensure relevant customs, trade and regulatory procedures are in place.